Principal Quality Engineer - Design Assurance (NPD)

Why Imperative Care

Do you want to make a real impact on patients?

What You’ll Do

• Lead development and execution of Design Assurance strategies and quality plans across the product development lifecycle to ensure compliance with applicable regulatory and internal quality requirements.
• Provide strategic quality input to product development teams and ensure effective implementation of design controls, verification, validation, and transfer activities.
• Establish and maintain quality engineering methodologies, procedures, and best practices supporting product realization and continuous improvement.
• Review product requirements, design outputs, test protocols, and development documentation to ensure alignment with quality and regulatory expectations.
• Utilize quality metrics and data analytics to identify trends, support decision-making, and drive proactive improvements.
• Lead Risk Management activities in accordance with ISO 14971 and internal procedures.
• Evaluate quality and reliability impacts from design changes, complaints, CAPAs, nonconformances, supplier issues, and process modifications.
• Conduct ongoing benefit-risk assessments throughout the product lifecycle and escalate unacceptable risks appropriately.
• Develop, review, and approve sterilization validation protocols, reports, requalification strategies, and associated documentation.
• Generate and maintain Biological Evaluation Plans (BEPs), assess testing outcomes, perform gap assessments, and determine biocompatibility testing strategies.
• Interpret laboratory results and translate findings into product and regulatory decisions.
• Support supplier qualification, audits, technical assessments, and remediation activities.
• Drive supplier quality improvements through effective CAPA, SCAR, and risk mitigation activities.
• Support and enhance Quality Management System processes to maintain compliance with applicable regulations and standards.
• Prepare and support technical documentation for regulatory submissions, audits, inspections, and management reviews.
• Support internal and external audits and serve as a technical representative during regulatory inspections.
• Act as a technical mentor and coach to Design Assurance, Quality Engineering, and cross-functional teams.
• Develop and deliver training on design assurance, sterilization, biocompatibility, and quality system requirements.
• Promote Quality Policy, Quality Objectives, and continuous improvement initiatives.
• Ensure applicable personnel are trained on procedures, GMP requirements, and regulatory expectations.

What You’ll Bring

• Bachelor’s degree in Engineering, Life Sciences, Microbiology, Biomedical Engineering, or related technical discipline with 12+ years of progressive experience in medical devices or regulated industries; or equivalent combination of education and experience.
• Master’s degree preferred.
• Experience supporting catheter-based, endovascular, neurovascular, or other Class II/III medical devices preferred.
• Demonstrated technical leadership in Design Assurance and product development quality.

Required Technical Competencies

• Deep expertise in medical device Design Controls and product development processes.
• Strong knowledge of FDA Quality System requirements, including 21 CFR Part 820 / QMSR and ISO 13485.
• Strong working knowledge of ISO 14971 risk management principles.
• Advanced experience with CAPA, nonconformance management, and supplier quality systems.
• Demonstrated experience supporting audits and regulatory inspections.

Preferred Specialized Expertise

• Extensive experience with terminal sterilization methods (EO preferred).
• Working knowledge of:
• ISO 11135 – Ethylene Oxide Sterilization
• ISO 11737 Series – Microbiological Methods
• ISO 11138 Series – Biological Indicators
• ISO 10993 Series – Biological Evaluation
• AAMI TIR52

Employee Benefits

• Stock options
• Competitive salaries
• 401k plan
• Health benefits
• Generous PTO
• Parental leave program

Schedule

This position is on-site, full-time.